Luminex FlexMAP 3D - India CDSCO Medical Device Registration

Luminex FlexMAP 3D is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000440_36e7a3532dbbb32e539fd21f8010755c_4db4125e5e53bb67e931a1d9adddd309. The license holder is Thermo Fisher Scientific India Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Luminex FlexMAP 3D

UID: IMP/IVD/2023/000440_36e7a3532dbbb32e539fd21f8010755c_4db4125e5e53bb67e931a1d9adddd309

License Holder

Thermo Fisher Scientific India Pvt. Ltd.

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.